Anti-Diabetic APIs
Premium Diabetes Management Active Pharmaceutical Ingredients for Global Healthcare
About Anti-Diabetic APIs
Holiness Pharmaceutical specializes in manufacturing and exporting high-quality Anti-Diabetic APIs for managing Type 2 diabetes mellitus. Our comprehensive portfolio includes biguanides, sulfonylureas, SGLT2 inhibitors, and DPP-4 inhibitors manufactured under WHO-GMP standards. We serve pharmaceutical companies worldwide, supporting the global fight against diabetes by ensuring access to effective blood glucose control medications.
Key Features
- WHO-GMP and ISO certified diabetes drug manufacturing
- Compliance with IP, BP, USP, and EP pharmacopeial standards
- Multiple therapeutic classes for comprehensive diabetes management
- Advanced synthesis technology for complex molecules
- Extended-release and standard release specifications
- Comprehensive genotoxic impurity control programs
- Complete regulatory documentation and DMF support
- Technical support for combination therapy development
Application Areas
Type 2 Diabetes Management
First-line and adjunct treatment for blood glucose control in Type 2 diabetes
Cardiovascular Risk Reduction
SGLT2 inhibitors providing heart failure and cardiovascular benefit
Weight Management
Diabetes medications with beneficial effects on body weight
Renal Protection
Drugs offering kidney protection in diabetic nephropathy
Combination Therapy
Fixed-dose combinations for enhanced glycemic control
Quality Assurance
Our anti-diabetic APIs undergo rigorous quality testing including HPLC analysis for purity and related substances, polymorphic form characterization, chiral purity assessment where applicable, genotoxic impurity screening per ICH M7 guidelines, residual solvent analysis, heavy metal testing, and comprehensive microbiological evaluation. Each batch is certified to meet stringent international standards for chronic therapy medications.
Our Anti-Diabetic APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Clopidogrel Bisulfate API | 120202-66-6 | BP/USP | API Powder | View Product |
Dapagliflozin API | 461432-26-8 | IP / BP / USP | API Powder | View Product |
Empagliflozin API | 864070-44-0 | BP/USP | API Powder | View Product |
Gliclazide API | 21187-98-4 | IP/BP/EP/USP | API Powder | View Product |
Linagliptin API | 668270-12-0 | IH | API Powder | View Product |
Metformin HCl API | 1115-70-4 | IP/BP/EP/USP | API Powder | View Product |
Semaglutide API | 910463-68-2 | BP/USP | API Powder | View Product |
Tirzepatide API | 2023788-19-2 | BP/USP | API Powder | View Product |
Vildagliptin API | 274901-16-5 | IH | API Powder | View Product |
Frequently Asked Questions
What are Anti-Diabetic APIs?
Anti-Diabetic APIs are active pharmaceutical ingredients that lower blood glucose levels in diabetes mellitus. They include various classes: biguanides (metformin) that reduce hepatic glucose production, sulfonylureas that stimulate insulin secretion, SGLT2 inhibitors that increase glucose excretion, and DPP-4 inhibitors that enhance incretin activity.
Which anti-diabetic APIs does Holiness Pharmaceutical manufacture?
We manufacture Metformin HCl (biguanide), Gliclazide (sulfonylurea), Dapagliflozin (SGLT2 inhibitor), and Linagliptin (DPP-4 inhibitor). All products meet international pharmacopeial standards and are available in specifications suitable for immediate-release, extended-release, and combination formulations.
Why is Metformin considered first-line therapy for Type 2 diabetes?
Metformin is preferred because it effectively lowers blood glucose without causing hypoglycemia or weight gain, has cardiovascular protective effects, is affordable and well-tolerated, and has decades of safety data. It works by reducing hepatic glucose production and improving insulin sensitivity, making it ideal for initial Type 2 diabetes management.
Do you manufacture extended-release Metformin?
Yes, we manufacture both immediate-release and extended-release grade Metformin HCl. Extended-release specifications include controlled particle size distribution, optimized polymorphic form for sustained dissolution, and low hygroscopicity. We provide technical support for developing once-daily formulations that improve patient compliance and reduce gastrointestinal side effects.
What are SGLT2 inhibitors and their benefits?
SGLT2 inhibitors like Dapagliflozin work by blocking glucose reabsorption in kidneys, causing glucose excretion in urine. Beyond glucose lowering, they provide cardiovascular benefits including reduced heart failure hospitalizations, kidney protection, blood pressure reduction, and modest weight loss. They represent a significant advancement in diabetes care.
Can you supply APIs for combination diabetes products?
Yes, we supply APIs for fixed-dose combinations such as Metformin-Dapagliflozin, Metformin-Linagliptin, and other combinations. We provide compatibility studies, stability data in combination, co-processing guidelines, and regulatory support for developing multi-drug formulations that simplify treatment regimens and improve adherence.
How do you control nitrosamine impurities in Metformin?
We implement stringent controls for nitrosamine impurities (NDMA) in Metformin following FDA and EMA guidelines. Our manufacturing process is designed to minimize nitrosamine formation, we use validated LC-MS methods for sensitive detection, and we ensure levels remain well below acceptable intake limits. Each batch is tested and certified for compliance.
What is the typical shelf life of anti-diabetic APIs?
Most anti-diabetic APIs have a shelf life of 2-3 years when stored properly in tightly closed containers at controlled room temperature protected from moisture and light. We conduct comprehensive stability studies under ICH guidelines and provide detailed storage recommendations. Since these are chronic therapy drugs, long-term stability is particularly important.